The Effects of Optimizing Post-operative Pain Management With Multi Modal Analgesia on Immune Suppression and Oncologic Outcome in Patients Undergoing Laparoscopic Colorectal Surgery

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03462836

Enrollment

Registered

2018-03-13

Start date

2019-04-30

Completion date

2021-09-28

Last updated

2019-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparoscopic Colorectal Resection Due to Cancer

Brief summary

Traditionally, pain control methods based on narcotic analgesics have been used to control severe pain after surgery, but this has resulted in side effects such as vomiting, constipation, dizziness, mental confusion due to drugs, and respiratory depression. This slowed the recovery of the patient after surgery and increased the duration of hospitalization, which had a negative impact on the patient 's prognosis. In addition, research has been conducted on the use of various painkillers in a variety of ways over the past decade to reduce the dose of narcotic analgesics and to increase the effectiveness of pain control, since studies of anesthetics and narcotic analgesics have shown immunosuppressive effects. This study investigate the effect of multimodal analgesics for postoperative pain control on immune function amd prognosis in patients undergoing laparoscopic colorectal cancer resection.

Interventions

DRUGIV ketamine/lidocaine/IV PCA apply

In the MA group, 1.0 mg / kg of ketamine is diluted to a total volume of 10 ml. Slowly apply for 1 minute during surgical drape. 1 mg / kg of Lidocaine is loaded at the beginning of surgery. Lidocaine 1.5 mg / kg / hr is administered until the end of the operation.

DRUGIV PCA only apply

IV PCA (fentanyl 10mcg/kg + nefopam (Acupan®) 80mg + Ramosetron (Nasea®) ) apply 30min before end of surgery.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 70 Years

Healthy volunteers

Inclusion criteria

1. elective laparoscopic colorectal resection due to colorectal cancer 2. curative, resectable operation 3. ASA classification Ⅰ-Ⅲ

Exclusion criteria

1. elective co-operation due to distance metastasis 2. preoperative chemo/radiation therapy 3. drug allergy to opioid, tramadol, local anesthetics 4. MAOi medication (within 14 days of surgery) 5. decreased hepatic/renal function 6. Patients who can not read the consent form or are not fluent in Korean (illiterate, foreigner 7. pregnant, lactating women 8. palliative surgery

Design outcomes

Primary

Measure	Time frame	Description
natural killer cell cytotoxicity	postoperative day #3	Natural killer cell cytotoxicity is measured with NK Vue Kit™(ATGen, Gyeonggi-do, Korea).

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026